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Merck · 1 hour ago

Senior Scientist, Engineering - Upstream Vaccines Drug Substance Commercialization

Lansdale, PA

Full-time

Hybrid

Mid, Senior Level

$115K/yr - $180K/yr

4+ years exp

Merck is part of the Manufacturing Division, focusing on Vaccines Drug Substance Commercialization. They are seeking a Senior Scientist to lead development and commercialization activities for multiple vaccine programs, responsible for upstream process development and collaboration with manufacturing teams.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Leading and executing large molecule upstream process development activities including lab-scale process development and process scale-up/scale-down

Executing lab scale experiments and authoring associated technical reports and documents

Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner

Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure

Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within our Company's network and at contract manufacturing organizations (CMOs)

Providing mentorship, coaching, and technical direction to other members of the team which may include direct reporting relationships

Qualification

Large molecule process developmentMicrobial physiology understandingLab scale experimental executionTechnical documentation authoringStatistical data analysisProject strategic planningDrug Substance knowledgeQuality by Design principlesLean Six Sigma principlesCoachingInnovationCommunication skillsMentorshipAdaptabilityDetail-oriented

Required

B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 6+ years of relevant experience; or Master's degree with 4+ years of relevant experience; or Ph.D. with relevant experience

Large molecule process development, or relevant experience including scaling (up and down) and tech transfer/facility fit of large molecule drug substance processes

Good understanding of microbial physiology and metabolism and ability to correlate to in-lab or shop floor fermentation events

Experience with small, lab, or pilot-scale large molecule fermentation and cell culture processes such as use of fermentors, bioreactors, and/or static cell culture

Expertise in lab scale experimental execution and experience with statistical data analysis (JMP, PI Vision, Spotfire, SIMCA, etc.) including presentation of results/conclusions

Experience with authoring technical documentation

Outstanding communication and people skills

Ability to foster a collaborative work environment focused on mentorship, coaching, and learning

Experience with project strategic planning

Outstanding communication and people skills

This role may require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing

Preferred

Knowledgeable in Drug Substance, end-to-end process development, including microbial, live virus vaccine, gene therapy, or oncolytic virus processes

Experience with upstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling

Experience with Quality by Design (QbD) and Lean Six Sigma principles

Ability to provide scientific mentorship and guidance to technical coworkers

Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA)

Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations